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Bowel Function After Minimally Invasive Urogynecologic Surgery

Primary Purpose

Functional Disorder of Intestine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Docusate
Bowel medications
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Functional Disorder of Intestine focused on measuring Urogynecology

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.

Procedures may include:

  • robot-assisted laparoscopic sacrocolpopexy
  • sacrospinous ligament suspension
  • uterosacral ligament suspension/paravaginal defect repair
  • colpocleisis
  • cystocele repair

Additional procedures may include:

  • hysterectomy
  • adnexectomy
  • culdoplasty
  • minimally invasive sling procedure (TVT or TOT)
  • periurethral collagen injections
  • enterocele repair

Exclusion Criteria:

  • Planning to undergo laparotomy.
  • Undergoing rectocele or perineocele repair as part of surgery.
  • Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.
  • Presence of a colostomy.
  • Chronic kidney disease
  • Insulin-dependent diabetes mellitus
  • Known cardiac disease
  • Gastric ulcers
  • Difficulty swallowing or esophageal stricture
  • Persistent nausea and vomiting
  • Signs and symptoms consistent with bowel obstruction

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Docusate

Bowel medications

Arm Description

Docusate is the standard of care regimen

Docusate, Miralax, Metamucil wafers, Bisacodyl suppository

Outcomes

Primary Outcome Measures

Time to First Post-op Bowel Movement
The time to first post-operative bowel movement was measured in hours after surgery.

Secondary Outcome Measures

Pain Level Associated With First Postoperative Bowel Movement
The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.
Consistency of First Postoperative Bowel Movement
The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale. The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid

Full Information

First Posted
January 5, 2010
Last Updated
September 21, 2015
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01044212
Brief Title
Bowel Function After Minimally Invasive Urogynecologic Surgery
Official Title
Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.
Detailed Description
See above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Disorder of Intestine
Keywords
Urogynecology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docusate
Arm Type
Active Comparator
Arm Description
Docusate is the standard of care regimen
Arm Title
Bowel medications
Arm Type
Experimental
Arm Description
Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Intervention Type
Drug
Intervention Name(s)
Docusate
Other Intervention Name(s)
Colace
Intervention Description
Docusate 100mg BID
Intervention Type
Drug
Intervention Name(s)
Bowel medications
Other Intervention Name(s)
Colace, Psyllium, Polyethylene glycol, Dulcolax
Intervention Description
Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID
Primary Outcome Measure Information:
Title
Time to First Post-op Bowel Movement
Description
The time to first post-operative bowel movement was measured in hours after surgery.
Time Frame
Within 1 week of surgery
Secondary Outcome Measure Information:
Title
Pain Level Associated With First Postoperative Bowel Movement
Description
The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.
Time Frame
Within 1 week of surgery
Title
Consistency of First Postoperative Bowel Movement
Description
The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale. The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid
Time Frame
Within 1 week of surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital. Procedures may include: robot-assisted laparoscopic sacrocolpopexy sacrospinous ligament suspension uterosacral ligament suspension/paravaginal defect repair colpocleisis cystocele repair Additional procedures may include: hysterectomy adnexectomy culdoplasty minimally invasive sling procedure (TVT or TOT) periurethral collagen injections enterocele repair Exclusion Criteria: Planning to undergo laparotomy. Undergoing rectocele or perineocele repair as part of surgery. Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment. Presence of a colostomy. Chronic kidney disease Insulin-dependent diabetes mellitus Known cardiac disease Gastric ulcers Difficulty swallowing or esophageal stricture Persistent nausea and vomiting Signs and symptoms consistent with bowel obstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunhilde Buchsbaum, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Bowel Function After Minimally Invasive Urogynecologic Surgery

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